Safety of SPD417 Combined With Other Psychotropic Medications in the Treatment of Bipolar I Disorder
Phase 3
Completed
- Conditions
- Bipolar Disorder
- Registration Number
- NCT00150605
- Lead Sponsor
- Validus Pharmaceuticals
- Brief Summary
The purpose of this study is to evaluate the safety of SPD417 when given with other psychotropic medications to treat bipolar I disorder.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
- DSM-IV criteria for Bipolar I disorder
- Screening YMRS score =>16
- Women of childbearing potential agree to take adequate precautions against contraception
- Currently receiving treatment with antipsychotic therapy or combination therapy of mood stabilizer and antipsychotic
Exclusion Criteria
- Hospitalization required for treatment of psychiatric symptoms
- Patients who meet DSM-IV for ultra-rapid cycling
- History of serious suicide attempt requiring medical intervention
- Female subjects who are pregnant or lactating, including females with a positive pregnancy test at screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety as assessed by treatment-emergent adverse events over 8 weeks of treatment
- Secondary Outcome Measures
Name Time Method YMRS Scale Clinical Global Impressions Scale - Bipolar Version HAM-D and MADRS Scales for Depression